DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet, coated 
Time-Cap Labs, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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329R DIP HCL

Active Ingredient

(in each caplet)

Diphenhydramine Hcl 25 mg

Ask a doctor before use if you have

glaucoma;

trouble urinating due to an enlarged prostate gland;

a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

Do not use

to make a child sleepy; with any other product containing diphenhydramine, even one used on skin.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Warnings

Do not use to make a child sleepy; Do not use with any other product containing diphenhydramine even one used on skin.

If pregnant or breast-feeding ask a health professional before use.

Uses: temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

runny nose; itchy water eyes sneezing;itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

When using this product

Avoid alcoholic drinks

marked drowsiness may occur

Alcohol, sedatives, and tranquilizers may increase drowsiness

Excitability may occur, especially in children

Be careful when driving a motor vehicle or operating machinery

Directions:

Take every 4 to 6 hours

Do not take more than 6 doses in 24 hours

Adults and children 12 years of age and over - 1 to 2 caplets

Children 6 to under 12 years of age - 1 caplet

Children under 6 years of age - Do not use this product in children under 6 years of age

Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide

Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

BULK LABEL IMAGEEnter section text here

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-329
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize7mm
FlavorImprint Code help
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-329-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2010
Labeler - Time-Cap Labs, Inc (037052099)
Registrant - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIBusiness Operations
Time-Cap Labs, Inc037052099manufacture(49483-329)

Revised: 12/2018
Document Id: 7d3b9a35-9e04-4289-e053-2a91aa0a5042
Set id: ed899055-0cbb-45bd-92c8-cbef2fc7c361
Version: 2
Effective Time: 20181217
 
Time-Cap Labs, Inc